Medical balloon having strengthening rods

ABSTRACT

A non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing the internal pressure within the balloon. The balloon comprises a balloon layer having an outer surface, the balloon layer including a base layer, a first reinforcing layer and a second reinforcing layer. The base layer is formed of a polymer material. The first reinforcing layer is one of either a plurality of discrete inelastic fibers oriented substantially parallel to the long axis of the balloon and a first layer of textile fabric material, the textile fabric material being one of a woven, knitted, braided and non-woven fabric. The second reinforcing layer is one of either at least one inelastic fiber wrapped around the circumference of the balloon substantially transverse to the long axis of the balloon and a second layer of textile fabric material, the textile fabric material being one of a woven, knitted, braided and non-woven fabric. At least one of the first and second reinforcing layers is a layer of textile fabric material. At least one strengthening rod is connected to the outer surface of the balloon layer.

CROSS REFERENCE TO RELATED APPLICATION

This application is a Continuation of U.S. patent application Ser. No.10/967,038, filed Oct. 15, 2004, entitled MEDICAL BALLOON HAVINGSTRENGTHENING RODS and issuing Apr. 8, 2008 as U.S. Pat. No. 7,354,419,the specifications of which is incorporated herein by reference.Currently pending U.S. application Ser. No. 11/690,735, filed Mar. 23,2007, and entitled NON-COMPLIANT MEDICAL BALLOON HAVING BRAIDED ORKNITTED REINFORCEMENT is a Continuation-in-Part of U.S. patentapplication Ser. No. 10/967,038.

TECHNICAL FIELD

This invention is related to medical balloons, in particularnon-compliant medical balloons used with a balloon catheter in medicalprocedures such as angioplasty.

BACKGROUND

Medical balloons have been widely used in medical procedures. Typically,an uninflated medical balloon is inserted into a body-space. When themedical balloon is inflated, the volume of the medical balloon expands,and the body-space is similarly expanded. In procedures such asangioplasty, the medical balloon may be used to open a collapsed orblocked artery.

Generally, medical balloons have been made of rubber or other compliantsubstances. To inflate the compliant medical balloons, pressure isincreased within the medical balloon, causing the compliant substance tostretch. As more and more pressure is applied to the inner surface ofthe medical balloon, the medical balloon expands larger and larger untilthe medical balloon bursts. A typical medical balloon will burst atapproximately 7-20 atmospheres or about 100-300 psi.

One of the principal difficulties in the use of medical balloons inmedical procedures is controlling the dimensions of the inflated medicalballoon. The pressure introduced must be sufficient to inflate themedical balloon to the proper size, however too much pressure mayoverinflate the balloon. Overinflating a medical balloon may cause theballoon to expand to a size that may cause stress on the body and mayeven damage the body. In the worst case, the excess of pressure mayburst the balloon, which can lead to serious complications.

While medical balloons are typically made to close tolerances so thatthe inflation pressure of the balloon is predictable, variations in thematerials used may cause compliant medical balloons to eitherunder-inflate or overinflate for a given pressure. The equipment used toinflate and control the pressure of the balloon must be carefullycalibrated and sufficiently accurate to deliver the expected pressurewith minimal deviations.

Medical balloons are commonly used in angioplasty, orthopaedics andother medical procedures where it is necessary to force a space withinthe body.

Non-compliance, or the ability not to expand beyond a predetermined sizeon pressure and to maintain substantially a profile, is a desiredcharacteristic for balloons. A non-compliant medical balloon is lesslikely to rupture or dissect the vessel as the balloon expands. Theburst pressure of a balloon is the average pressure required to rupturea balloon; usually measured at body temperature.

Further difficulties often arise in guiding a balloon catheter into adesired location in a patient due to the friction between the apparatusand the vessel through which the apparatus passes. The result of thisfriction may be failure of the balloon due to abrasion and punctureduring handling and use. Failure may also result from over-inflation.

Therefore, what is needed is a non-compliant medical balloon that can beinflated with pressure such that the balloon maintains its inflateddimensions without further expanding when additional pressure isapplied.

SUMMARY

A non-compliant medical balloon may be changed from a deflated state toan inflated state by increasing pressure within the balloon. Thenon-compliant medical balloon is composed of a woven fabric layercomposed of at least two woven fabric fibers forming an angle. The angleremains substantially unchanged when the balloon changes from a deflatedstate to an inflated state.

A non-compliant medical balloon may be changed from a deflated state toan inflated state by increasing the internal pressure within theballoon, and when the balloon is fully inflated, it has a length anddiameter that do not substantially change as the internal pressurefurther increases. The balloon comprises a balloon layer having an outersurface, the balloon layer including a base layer, a first reinforcinglayer and a second reinforcing layer. The base layer is formed of apolymer material. The first reinforcing layer is disposed over the baselayer. The first reinforcing layer is one of either a plurality ofdiscrete inelastic fibers oriented substantially parallel to the longaxis of the balloon and a first layer of textile fabric material, thetextile fabric material being one of a woven, knitted, braided andnon-woven fabric. The second reinforcing layer is applied at leastpartially over the first reinforcing layer. The second reinforcing layeris one of either at least one inelastic fiber wrapped around thecircumference of the balloon substantially transverse to the long axisof the balloon and a second layer of textile fabric material, thetextile fabric material being one of a woven, knitted, braided andnon-woven fabric. At least one of the first and second reinforcinglayers is one of the first and the second layer of textile fabricmaterial. At least one strengthening rod is connected to the outersurface of the balloon layer.

A non-compliant medical balloon catheter may be changed from a deflatedstate to an inflated state by increasing the internal pressure withinthe balloon, and when the balloon is fully inflated, it has a length anddiameter that do not substantially change as the internal pressurefurther increases. The balloon catheter comprises a catheter tube and aballoon layer having an outer surface. The balloon layer includes a baselayer, a first reinforcing layer, and a second reinforcing layer. Thebase layer is formed of a polymer material. The first reinforcing layeroverlies the base layer and the second reinforcing layer at leastpartially overlies the first reinforcing layer. One of the first andsecond reinforcing layers is a textile fabric material, the textilefabric material being one of a woven, knitted, braided and non-wovenfabric comprising a plurality of fibers oriented at angles to oneanother. The other of the first and second reinforcing layers is formedof inelastic fibers aligned in one of either a first direction and asecond direction, the first direction being substantially parallel tothe long axis of the balloon and the second direction being around thecircumference of the balloon substantially transverse to the long axisof the balloon. At least one strengthening rod is connected to the outersurface of the balloon layer.

A method of forming a non-compliant medical balloon that may be changedfrom a deflated state to an inflated state by increasing the internalpressure within the balloon. A base layer is formed from a polymermaterial in the shape of the inflated balloon having a long axis and acircumference. A first reinforcing layer is applied over the base layer,the first reinforcing layer being one of either a plurality of discreteinelastic fibers oriented substantially parallel to the long axis of theballoon and a first layer of textile fabric material, the textile fabricmaterial being one of a woven, knitted, braided and non-woven fabric. Asecond reinforcing layer is applied at least partially over the firstreinforcing layer, the second reinforcing layer being one of either atleast one inelastic fiber wrapped around the circumference of theballoon substantially transverse to the long axis of the balloon and asecond layer of textile fabric material, the textile fabric materialbeing one of a woven, knitted, braided and non-woven fabric. At leastone of the first and second reinforcing layers is one of the first andsecond layer of textile fabric material. At least one strengthening rodis affixed to the outer surface of the balloon layer formed by theprevious steps.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a semi-cross section of a fiber-reinforced medicalballoon;

FIG. 1B illustrates a deflated fiber-reinforced medical balloon;

FIG. 2 illustrates an inflated balloon base layer;

FIG. 3 illustrates a balloon-shaped mandrel;

FIG. 4 illustrates a balloon base layer having an adhesive layer;

FIG. 5 illustrates a first fiber layer;

FIG. 6 illustrates a cross-section of a balloon base layer, adhesivelayer and first fiber layer;

FIG. 7 illustrates a cross-section of a balloon base layer, adhesivelayer and first fiber layer;

FIG. 8 illustrates a cross-section of a balloon base layer, an adhesivelayer, a first fiber layer, a second fiber layer, an outer coating layerand a final layer;

FIG. 9 illustrates a cross-section of a balloon base layer, an adhesivelayer, a first fiber layer, a second fiber layer and an outer coatinglayer;

FIG. 10 illustrates a fiber-reinforced medical balloon with alongitudinal first fiber layer and a circumferential second fiber layer;

FIG. 11 illustrates a fiber-reinforced medical balloon with alongitudinal first fiber layer and an angled second fiber layer;

FIG. 12 illustrates a fiber-reinforced medical balloon having an angledfirst fiber layer and a circumferential second fiber layer;

FIG. 13 illustrates a fiber-reinforced medical balloon having alongitudinal first fiber layer and an angled second fiber layer;

FIG. 14 illustrates a fiber-reinforced medical balloon having an angledfirst fiber layer and an angled second fiber layer;

FIG. 15 illustrates a cross-section of a balloon base layer, an adhesivelayer, a first fiber layer, a second fiber layer, a third fiber layerand an outer coating layer;

FIG. 16 illustrates a fiber-reinforced medical balloon having alongitudinal first fiber layer, an angled second fiber layer and a thirdfiber layer;

FIG. 17A illustrates a fiber-reinforced medical balloon having a wovenfiber layer;

FIG. 17B is an enlarged illustration of a portion of the balloon of FIG.17A;

FIG. 18 illustrates a cross-section including a woven fiber layer;

FIG. 19 illustrates a fabric layer including taut parallel fibers;

FIG. 20 illustrates a fabric layer including matted fibers;

FIG. 21 illustrates a medical balloon having attached strengtheningrods;

FIG. 22 illustrates a cross-section of a medical balloon having attachedstrengthening rods;

FIG. 23 illustrates a balloon catheter;

FIG. 24 illustrates a cross-section of a balloon catheter tube;

FIG. 25 illustrates a deflated fiber-reinforced medical balloon;

FIG. 26 illustrates a balloon catheter, connector and syringe;

FIG. 27 illustrates a balloon catheter and a pressurized fluid deliverysystem;

FIG. 28 illustrates a cross-section of a blocked vessel;

FIG. 29 illustrates a cross-section of a blocked vessel containing aninflated balloon catheter;

FIG. 30 illustrates vertebrae and a vertebral body; and

FIG. 31 illustrates vertebrae treated with a balloon catheter.

DETAILED DESCRIPTION

Referring now to the drawings, wherein like reference numbers are usedto designate like elements throughout the various views, severalembodiments of the present invention are further described. The figuresare not necessarily drawn to scale, and in some instances the drawingshave been exaggerated or simplified for illustrative purposes only. Oneof ordinary skill in the art will appreciate the many possibleapplications and variations of the present invention based on thefollowing examples of possible embodiments of the present invention.

With reference to FIG. 1A, a cross section of an inflatedfiber-reinforced medical balloon 10 is shown. With reference to FIG. 1B,a cross section of a deflated fiber-reinforced medical balloon 30, isshown. The fiber-reinforced balloon, 10 and 30, is substantiallynon-compliant, having limited expansion characteristics. As pressure isapplied to the interior of a deflated balloon 30 through catheter inletconnector 34, the deflated balloon 30 inflates. Balloon folds 31 inouter surface 32 decrease the diameter of the medical balloon 30 forinsertion. As the deflated medical balloon 30 inflates, the balloonfolds 31 substantially disappear until the balloon 30 reaches aninflated size, as indicated by balloon 10 in FIG. 1A. Because themedical balloon 10 is non-compliant, once the balloon 10 is fullyinflated, it has a length 118 and diameter 116 that do not change as thepressure on the interior of the balloon 10 increases.

The diameter 116 of an inflated fiber-reinforced medical balloon 10 inaccordance with the one embodiment may be about ten millimeters.Balloons 10 with a diameter 116 of about five millimeters to twentymillimeters have been developed. The length 118 of an inflatedfiber-reinforced medical balloon 10 in accordance with one embodimentmay be about eight centimeters. Balloons 10 with a length 118 of twocentimeters, three centimeters, four centimeters, six centimeters andeight centimeters have been made. The inclination angle of the coneportion 108 of an inflated fiber-reinforced medical balloon 10 inaccordance with the disclosed embodiment may be about twenty degrees. Itwill be recognized by those having skill in the art that thefiber-reinforced balloon 10 could be made in a wide variety of diameters116 and lengths 118 and with a variety of inclinations at the coneportion 108 of the balloon.

The fiber-reinforced balloon 10 is generally suitable for use as amedical balloon. Medical balloons are commonly used in angioplasty,orthopaedics and other medical procedures where it is necessary tocreate a space within the body. It may be recognized by those skilled inthe art that the qualities of a fiber-reinforced balloon 10 may make theballoon 10 suitable for other uses. The fiber-reinforced balloons 10 maybe used non-medically to create space or otherwise. The fiber-reinforcedballoons 10 may be used in ways beyond the present uses of medicalballoons.

The fiber-reinforced medical balloon 10 may integrally include baseballoon layer 100, a first layer of thin inelastic fibers 12 made up ofone or more fibers 13. The fiber-reinforced medical balloon 10 mayintegrally include a second layer of thin inelastic fibers 14 made up ofone or more fibers 15. An outer coating layer 16 may be integrallyincluded in the fiber-reinforced medical balloon 10.

Each fiber 13 is typically fixed relative to other fibers in the firstfiber layer 12 and other fibers in the balloon 10. The thin inelasticfibers 13 of the first fiber layer 12 may be characterized by a hightensile strength. As required for medical uses, the fiber-reinforcedballoons 10 provide superior burst strength. The fiber-reinforcedballoon 10 may also resist abrasion, cuts and punctures. It may berecognized that enhanced structural integrity may result from the fiberreinforcement.

With reference to FIG. 2, a fiber reinforced medical balloon may includea base layer 100. The base layer 100 may be in the shape of a standardmedical balloon, ore any other suitable shape. A standard polymericballoon may function as a base layer 100 for the fiber-reinforcedmedical balloon 10. The base balloon layer 100 typically includes afirst passage region 102 which may be formed as a narrow cylinderfashioned to attach to the tube of a catheter. A second passage region110 may be similarly formed as a narrow tube. The first passage region102 is formed adjacent to a first cone region 104. The first cone region104 expands the diameter of the first passage region to meet the barrelregion 106, marked by a first edge 114. The first cone region 104 istypically constructed at an angle of about twelve to twenty degrees.

The barrel region 106 is characterized by a length 118 and a diameter116. The barrel region 106 meets the second cone region 108 at a secondedge 112. The second cone 108 meets the second passage region 110.

The base layer balloon 100 is typically formed of a thin film polymericmaterial, or other suitable materials with high strength relative tofilm thickness. Polymers and copolymers that can be used for the baseballoon 100 include the conventional polymers and copolymers used inmedical balloon construction, such as, but not limited to, polyethylene,(PET), polycaprolactam, polyesters, polyethers, polyamides,polyurethanes, polyimides, ABS, nylons, copolymers, polyester/polyetherblock copolymers, ionomer resins, liquid crystal polymers, and rigid rodpolymers. The base layer balloon 100 may typically be formed as ablow-molded balloon of highly oriented polyethylene terephthalate (PET).

The strength of the fiber-reinforced balloons 10 permits the use of baselayer balloons 100 having a wall thickness 120 less than conventional orprior art balloons without sacrifice of burst strength, abrasionresistance, or puncture resistance. In accordance with the disclosedembodiment, the base layer balloon 100 may have a wall thickness 120 of0.0008 inch. It will be recognized by those skilled in the art that thewall thickness 120 of the base layer balloon 100 may be diminished asrequired. Because it is possible for a fiber-reinforced balloon 10 toomit the PET balloon base layer 100, the balloon wall thickness 120 canbe selected to be arbitrarily small.

The balloon base layer 100 may be omitted from a fiber-reinforcedballoon 10, in accordance with one embodiment. The base layer of apolymer 100, which has been cured into the shape of a balloon may beformed. This polymer base layer 100 forms the inner polymeric wall ofthe fiber reinforced balloon. With reference to FIG. 3, a removablemandrel 122 may be used as a base for application of the polymer. Afterthe polymer is cured, the mandrel 122 may be removed by standard meanssuch as an application of heat to destructure the mandrel 122.

A removable base balloon may be used as the mandrel 122. The mandrel 122may be made from a variety of materials. The mandrel 122 may be made inthe shape of the interior wall of the desired finished balloon. Themandrel 122 may be made of collapsible metal or polymeric bladder,foams, waxes, low-melting metal alloys, and the like. Once the compositeballoon is developed and laminated, the base balloon or mandrel 122 maybe removed by melting, dissolving, fracturing, compressing, pressurizingor other suitable removal techniques.

In using the mandrel 122 arrangement, alternative processing techniquescan be employed which do not limit the parameters of temperature, force,pressure, etc., during the lamentation process. The materials used forthe balloon construction are not limited to those which conform to thepresent art of forming a balloon with pressure, temperature and force,such as, for example, those utilized for forming a balloon from a tubemade from a polymeric material. Stronger fiber-reinforced balloons 10,with higher pressure and better damage resistance, can be formed withsmaller geometries, in particular balloons having thinner walls. Theresulting fiber-reinforced balloons 10 can be stronger, softer and moreflexible. This minimizes the necessary introducer passage whileproviding higher performance at higher pressures.

With reference to FIG. 4, integral layers of the fiber-reinforcedballoon 10 are shown. In accordance a disclosed embodiment, a thincoating of an adhesive 126 is applied to the inflated polymer balloonbase layer 100 or to the polymer-coated mandrel 122 prior to applyingthe first layer inelastic fibers 12. The adhesive 126 binds the fibers13 sufficiently to hold them in position when the fibers 13 are placedon the base layer balloon 100. In accordance with one embodiment, a verythin coat of 3M-75 adhesive 126 is applied to the base layer balloon100. 3M-75 is a tacky adhesive available from the 3M Company,Minneapolis, Minn.

With reference to FIG. 5, integral layers of the fiber-reinforcedballoon 10 are shown. One or more fibers 13 are applied to the polymericbase layer 100 to form a first fiber layer 12. The first fiber layer 12may be referred to as the “primary wind.”

The fibers 13 of the first fiber layer 12 may be inelastic fiber,typically made of an inelastic fibrous material. An inelastic fiber is afiber that has very minimal elasticity or stretch over a given range ofpressures. Some fibrous materials are generally classified as inelasticalthough the all fibrous material may have a detectable, but minimal,elasticity or stretch at a given pressure.

The fibers 13 of the first fiber layer 12 may be high-strength fibers,typically made of a high-strength fibrous material. Some high strengthinelastic fibrous materials may include Kevlar, Vectran, Spectra,Dacron, Dyneema, Terlon (PBT), Zylon (PBO), Polyimide (PIM), other ultrahigh molecular weight polyethylene, aramids, and the like.

In a disclosed embodiment, the fibers 13 of the first fiber layer 12 areribbon-shaped, where the width of the fiber is larger than the thicknessof the fiber. The fibers 13 may be flat so that the fiber has arectangular cross-section. The fibers 13 used in the initial layer offibers 12 may all be fibers 13 made of the same material and the sameshape. Fibers 13 made from different materials may be used in theinitial fiber layer 12. Fibers 13 made in different shapes may be usedin the initial fiber layer 12.

Ultra High Molecular Weight Polyethylene fiber 13, which has beenflattened on a roll mill, may be used to form the first fiber layer 12.To the flattened fiber 13 is applied a thin coat of a solution ofpolyurethane adhesive in a 60-40 solution of methylene chloride andmethylethylketone. The fibers 13 may be arranged as 30 longitudinalfibers, each substantially equal in length to the length 118 of the longaxis of the balloon 100.

The fibers 13 of the initial fiber layer 12, in accordance with thedisclosed embodiment, are arranged so that each fiber 13 issubstantially parallel to the long axis of the balloon 100.Longitudinally placed fibers 13 are fibers 13 placed along the long axisof the balloon 100. The fibers 13 may be parallel to each other. Thedensity of the fibers 13 in the initial fiber layer 12 is determined bythe number of fibers 13 or fiber winds per inch and the thickness of thefibers 13.

In a disclosed embodiment of the first fiber layer 12 havinglongitudinally-placed fibers 13, a fiber density of generally about 15to 30 fibers 13 having a fiber thickness of about 0.0005 to 0.001 inchand placed equidistant from one another provide adequate strength for astandard-sized fiber-reinforced medical balloon 10. Kevlar® fibers 13may be positioned along the length of the balloon 100 to form the firstfiber layer 12. Each of the fibers 13 is substantially equal in lengthto the length 118 of the long axis of the balloon 100. Twenty-fourfibers 13 may be positioned substantially equally spaced from eachother.

The fiber 13 used for the primary wind may have a thickness of 0.0006inch. Fiber 13 with a thickness of 0.0005 inch may be used instead. Theresulting composite balloon 10 is axially and radially non-compliant atvery high working pressures. The fiber-reinforced balloon 10 has veryhigh tensile strength and abrasion and puncture resistance. Highstrength ultra-high molecular weight polyethylene fiber may be used.

The first fiber layer 12 may prevent longitudinal extension of thecompleted fiber-reinforced balloon 10. The longitudinally placed fibers13 may be parallel to or substantially parallel to the long axis of thebase layer balloon 100 for maximum longitudinal stability of thefiber-reinforced balloon 10.

With reference to FIG. 6, a cross-section of the integral layers of afiber-reinforced balloon 10 is depicted. A base layer 100 is coated withan adhesive layer 126. The first fiber layer 12 is positioned on thebase layer 100, held at least partially in place by the adhesive layer126.

In accordance with a disclosed embodiment, a second fiber layer 14 madewith one or more high-strength inelastic fibers 15 is positioned alongcircumference of the balloon 100, as shown in FIG. 7. Thecircumferentially placed fibers 15 may be transverse or substantiallytransverse to the long axis of the balloon 100. The circumferentialfibers 15 may prevent or minimize distension of the balloon diameter 116at pressures between the minimal inflation pressure and the balloonburst pressure.

The fibers 15 of the second fiber layer 14 may be inelastic fiber,typically made of an inelastic fibrous material. An inelastic fiber is amember of a group of fibers that have very minimal elasticity or stretchin a given range of pressures. Some fibrous materials are generallyclassified as inelastic although the all fibrous material may have adetectable, but minimal elasticity or stretch at a given pressure.

The fibers 15 of the second fiber layer 14 may be high-strength fibers,typically made of a high-strength fibrous material. Some high strengthinelastic fibrous materials may include Kevlar, Vectran, Spectra,Dacron, Dyneema, Terlon (PBT), Zylon (PBO), Polyimide (PIM), other ultrahigh molecular weight polyethylene, aramids, and the like.

In a disclosed embodiment, the fibers 15 of the second fiber layer 14are ribbon-shaped, where the width of the fiber is larger than thethickness of the fiber. The fibers 15 may be flat so that the fiber hasa rectangular cross-section. The fibers 15 used in the second layer offibers 14 may all be fibers 15 made of the same material and the sameshape. Fibers 15 made from different materials may be used in the secondfiber layer 14. Fibers 15 made in different shapes may be used in thesecond fiber layer 14.

Ultra High Molecular Weight Polyethylene fiber 15, which has beenflattened on a roll mill, may be used to form the second fiber layer 14.To the flattened fiber 15 is applied a thin coat of a solution ofpolyurethene adhesive in a 60-40 solution of methylene chloride andmethylethylketone. The fibers 15 may be arranged as a second fiber layer14 may have a fiber density of 54 wraps per inch. The fibers 15 may becoated with the adhesive solution to form the outer coating layer 16.

The fibers 15 of the second fiber layer 14 may be perpendicular to orsubstantially perpendicular to the fibers 13 placed longitudinally toform the first fiber layer 12. This transverse placement of the firstfiber layer 12 and the second fiber layer 14 allows for maximum radialstability of the fiber-reinforced balloon 10. The placement of the fiberlayers 12 and 14 distributes the force on the balloon surface equally,creating pixelized pressure points of generally equal shape, size anddensity.

The fibers 13 of the first fiber layer 12 may be the same as ordifferent from the fiber 15 of the second fiber layer 14. Specifically,the fibers 15 of the second fiber layer 14 may be made of a differentmaterial or materials than the fibers 13 of the first layer 12. Thefibers 15 of the second layer 14 may be shaped differently from thefibers 13 of the first fiber layer 12. The characteristics of the fibersor combination of fibers used for the first or second fiber layers maybe determined from the specific properties required from the resultingfiber-reinforced balloon 10.

With respect to the fiber density of the second fiber layer 14, inaccordance with the disclosed embodiment, fiber 15 having a thickness ofabout 0.0005 to 0.001 inch and arranged in parallel lines with about 50to 80 wraps per inch provides generally adequate strength. A singlefiber 15 may preferably form the second fiber layer 14, with the fiber15 wound in a generally parallel series of circumferential continuousloops.

For a standard-sized medical balloon 10, the single fiber 15 may beabout 75-100 inches long. Kevlar® fiber 15 may be applied radiallyaround the circumference of and over substantially the entire length 118of the long axis of the balloon 100. The fiber 15 has a thickness of0.0006 inch and is applied at a wind density of 60 wraps per inch.

With reference to FIG. 8, a cross section of the integral layers of afiber-reinforced medical balloon 10 is shown. The first fiber layer 12and the second fiber layer 14 may be coated with an outer coating layer16. The outer coating layer 16 may be, in the disclosed embodiment, apolymeric solution. The outer coating layer 16 may be a cured polymericsolution. A fiber-wound based PET balloon 10 may be coated with a 10%solution of 5265 polyurethane in dimethylacetamide (DMA) that has beenallowed to cure at room temperature. Five additional coatings of thepolurethane solution may be used to form the outer coating layer 16. Theresulting composite fiber-reinforced balloon 10 is non-compliant andexhibits superior burst strength and abrasion and puncture resistance.One or more additional protective layers 18 may be positioned on theouter coating layer 16, to provide additional layers of protection.

A composite structure typically including balloon base layer 100, anadhesive 126, a first fiber layer 12, a second fiber layer 14 and anouter coating layer 16 forms a composite, non-compliant fiber-reinforcedballoon 10 particularly suitable for medical uses. The outer coatinglayer 16 of the fiber/polymeric matrix secures and bonds the fibers 13and 15 to the underlying PET balloon base layer 100. Typically, therelative movement of the fibers 13 and 15 are fixed when thefiber-reinforced balloon 10 is initially deflated, and then subsequentlyinflated and deflated during use.

A wax mandrel 122 may be coated with a very thin layer (0.0002 inch) ofpolyurethane to form a balloon base layer 100. After the polyurethanehas been cured, adhesive 126 and fibers may be applied to form a firstfiber layer 12 and a second fiber layer 14. Several coats ofpolyurethane may be applied to form the outer coating layer 16. The waxmandrel 122 is then exhausted by dissolving in hot water to form anon-compliant, very high strength, abrasion-resistant, compositefiber-reinforced balloon 10.

A balloon-shaped solid mandrel 122 made of a low melting temperaturemetal alloy may be coated with a thin layer of polyurethene/DMA solution(10%) as a base layer 100. Fibers may be positioned to form a firstfiber layer 12 and a second fiber layer 14. The fibers 13 and 15 may becoated with a polyurethene/DMA outer coating layer 16.

A mandrel 122 may be coated with a very thin layer of PIM polyimide(2,2-dimethylbenzidine) in solution in cyclopentanone as a base layer100. Polyimide fibers may be positioned to form a first fiber layer 12and the second fiber layer 14. The composite balloon 10 may have anouter coating layer 16 of the PIM solution. When the mandrel 122 isremoved, the fiber-reinforced balloon 10 is characterized by a highstrength and puncture resistance. The balloon 10 will be formed with anextremely cohesive fiber/matrix composite wall that is resistant todelamination.

With reference to FIG. 9, a cross-section of the integral layers of afiber-reinforced balloon 10 in accordance with one embodiment is shown.The longitudinal first fiber layer 12 may be replaced by alongitudinally oriented thin film 20 made of polyimide film. The film 20may be cut into a balloon-shaped pattern and applied to the mandrel 122,over which the polyimide hoop fibers 14 and the PIM solution 16 may beapplied.

The thickness of the polymeric outer coating layer 16 may be determinedby the characteristics of the desired fiber-reinforced balloon 10. Thepolymeric solution used for the outer coating layer 16 may be made ofthe same polymer as the polymer base balloon layer 100. The outercoating layer 16 may be made from a different polymer than the inflatedpolymeric balloon base layer 100. Where the polymers are different, thepolymers may be chosen to be compatible to reduce or prevent separationof the composite balloon 10.

Polymers and copolymers that may be used as the outer coating layer 16of the fiber/polymeric matrix include the conventional polymers andcopolymers used in medical balloon construction. Typical suitablesubstances may include polyethylene, nylons, polyethylene terephthalate(PET), polycaprolactam, polyesters, polyethers, polyamides,polyurethanes, polyimides, ABS copolymers, polyester/polyether blockcopolymers, ionomer resins, liquid crystal polymers, and rigid rodpolymers.

A final layer 18, generally a homogeneous polymeric or other materiallayer, may be positioned on the outer layer 16 as a protective layer.The final laminate 18 may be applied as a film, a spray coating, bydipping or other deposition process. The resulting final laminate 18 isrendered more resistant to damage of the fibers. The final compositeimproves resistance to abrasion. The added layer 18 provides improvedstent retention for deployment. The polymeric final layer 18 lowers thefinal durometer of the balloon surface.

While the fiber reinforced balloon 10 having a balloon base layer 100, afirst fiber layer 12 and second fiber layer 14 and an outer coatinglayer 16 forms the balloon 10 of the disclosed embodiment, it will berecognized by those skilled in the art that other variations of theembodiment may be formed. In particular, a variety of combinations offiber layers, fiber layer orientations and fabrics may be used to formvarious medical balloons having various attributes.

With reference to FIG. 10, a fiber reinforced balloon 10 in accordancewith the disclosed embodiment, is shown. In this embodiment, the fibers13 of the first fiber layer 12 lie parallel to the long axis of theballoon 10.

With reference to FIG. 11, a fiber reinforced balloon 45, in accordancewith another embodiment is shown. The fiber-reinforced balloon 45 mayinclude a first fiber layer 46 with fibers 47 that lie at an angle tothe longitudinal axis of the balloon 45. In this embodiment, neither thefibers 47 of the first fiber layer 46 nor the fibers 49 of the secondfiber layer 48 are positioned parallel to the longitudinal axis of theballoon 45. In accordance with one embodiment, the fibers 47 of thefirst fiber layer 46 may be positioned parallel to a line at a fivedegree angle to a line parallel to the longitudinal axis of the balloonbase layer 100. In accordance with another embodiment, the fibers 47 ofthe first fiber layer 46 may be positioned parallel to a line at atwenty degree angle to a line parallel to the longitudinal axis of theballoon base layer 100.

In accordance with another embodiment, the fibers 47 of the first fiberlayer 46 may be positioned parallel to a line at a thirty degree angleto a line parallel to the longitudinal axis of the balloon base layer100. In accordance with another embodiment, the fibers 47 of the firstfiber layer 46 may be positioned parallel to a line at a forty-fivedegree angle to a line parallel to the longitudinal axis of the balloonbase layer 100. It will be apparent to those having skill in the artthat the fibers 47 may be placed at any appropriate angle.

In accordance with the disclosed embodiment, the fibers 15 of the secondfiber layer 14 lie parallel to the circumference of the balloon 10. Withreference to FIG. 12, a fiber-reinforced balloon 40 in accordance withanother embodiment is shown. The fiber reinforced balloon 40 may includea second fiber layer 43 with fibers 44 that lie at an angle to thecircumference of the balloon 40. In accordance with one embodiment, thefibers 44 of the second fiber layer 43 may be positioned parallel to aline at a five degree angle to a line parallel to the circumference ofthe base balloon 100.

In accordance with one embodiment, the fiber 44 of the second fiberlayer 43 may be positioned parallel to a line at a twenty degree angleto a line parallel to the circumference of the base balloon 100. Inaccordance with one embodiment, the fiber 44 of the second fiber layer43 may be positioned parallel to a line at a thirty degree angle to aline parallel to the circumference of the base balloon 100. Inaccordance with one embodiment, the fiber 44 of the second fiber layer43 may be positioned parallel to a line at a forty-five degree angle toa line parallel to the circumference of the base balloon 100. It will beapparent to those skilled in the art that the fibers 44 may be placed atany appropriate angle.

In accordance with the disclosed embodiment, the fibers 42 of the firstfiber layer 41 and the fibers 44 of the second fiber layer 43 arepositioned perpendicularly relative to each other. With reference toFIG. 13, a fiber-reinforced balloon 50 in accordance with anotherembodiment is shown. A fiber-reinforced balloon 50 may include fibers 52of the first fiber layer 51 and fibers 54 of the second fiber layer 53positioned relatively at an angle other than a right angle.

With reference to FIG. 14, a fiber-reinforced balloon 55 in accordancewith one embodiment is shown. It will be apparent to those having skillin the art that the fibers 57 of the first fiber layer 56 and the fiber59 of the second fiber layer 58 may be positioned at any appropriateangle. Placing the fiber 57 of the first fiber layer 56 and the fibers59 of the second fiber layer 58 parallel to each other will result in aballoon 55 with less strength than a balloon 55 where the fibers 57 and59 are positioned relatively at an angle.

With reference to FIG. 15, a fiber-reinforced balloon 60 in accordancewith another embodiment is shown. The fiber-reinforced balloon 60 mayinclude a third fiber layer 63 may be positioned atop the second fiberlayer 62. Typically, the fibers 66 of the third fiber layer 63 may forman angle with the fibers 64 of the second fiber layer 62 and the fibers67 of the first fiber layer 61. The fibers 66 of the third fiber layer63 may be formed of the same material as the fibers 64 of the secondfiber layer 62 or the fiber 67 of the first fiber layer 61 or both.

The fibers 66 of the third fiber layer 63 may be formed in the sameshape as the fibers 64 of the second fiber layer 62 or the fibers 67 ofthe first fiber layer 61 or both. An adhesive 126 may be used to securethe placement of the fibers 66 of the third fiber layer 63 on the fibers64 of the second fiber layer 62.

In one embodiment, the fibers 64 of the second fiber layer 62 may bepositioned at a small acute angle, typically about 10 degrees to thelongitudinal fibers 67 of the first fiber layer 61. A third fiber layer63 having a fiber 66 at an opposite angle relative to the longitudinalfibers 67 of the first fiber layer 61 may help minimizing radialdistension. FIG. 16 depicts a fiber-reinforced balloon 60 having a firstfiber layer 61, a second fiber layer 62 and a third fiber layer 63.

With reference to FIGS. 17A and 17B, a fiber-reinforced balloon 70having a woven fiber layer 73 in accordance with one embodiment isshown. Medical textile products are based on fabrics, of which there arefour types: woven, knitted, braided, and non-woven. Weave patterns aretypically comprised of two thread systems, designated warp and weft.Warp threads 72 run along the length of the fabric, circumferentiallywhen the fabric is applied to a balloon 70. Weft threads 71 run alongthe width. It should be noted that these designations are arbitrary andthe direction of the warp and weft threads may not correspond to theaxis or circumference of a balloon. In the process of weaving, threadsare interlaced in different ways to form various weave patterns. It willbe recognized that fiber-reinforced balloon 70 could be made using anysuitable fabric, whether woven, knitted, braided or non-woven.

The threads of the fabric may be formed from a variety of substances,typically polymers. In selecting a polymer, it should be recognized thatsuitable polymer chains may be linear, long, and flexible. The sidegroups should be simple, small, or polar. Suitable polymers may bedissolvable or meltable for extrusion. Chains should be capable of beingoriented and crystallized.

Common fiber-forming polymers include cellulosics (linen, cotton, rayon,acetate), proteins (wool, silk), polyamides, polyester (PET), olefins,vinyls, acrylics, polytetrafluoroethylene (PTFE), polyphenylene sulfide(PPS), aramids (Kevlar, Nomex), and polyurethanes (Lycra, Pellethane,Biomer). Each of these materials is unique in chemical structure andpotential properties.

The woven fiber layer 73 typically covers the entire length andcircumference of the barrel of the balloon 70. To form a restrainingstructure integral to the fiber-reinforced balloon 70, weft fibers 71and warp fibers 72 may be woven by passing a weft fiber 71 over and thenunder the warp fibers 72 across the surface of the balloon 70. The wovenweft fibers 71 and warp fibers 72 may form a woven fiber layer or otherfabric layer 74. The woven fiber layer 74 may be used in place of eitherthe first fiber layer 12 or the second fiber layer 14 as those layersare described in other embodiments.

A weft fiber 71 is typically woven with a warp fiber 72 in aninterlocking fashion with each fiber passing over and then under thesequence of transverse fibers. It will be recognized by those skilled inthe art that the weft fibers 71 may be woven in a variety of weavepatterns with warp fibers 72. Pre-woven fabric may be applied as a wovenfabric layer 74 to the balloon directly. An adhesive layer 126 may beused to fix the position of the fabric layer 74 on the base balloonlayer 100.

With reference to FIG. 18, a cross-section of a fiber-reinforced balloon70 including a woven fabric layer 74 is shown. In one embodiment, thewoven fabric layer 74 may be coated with a polymer. In accordance withanother embodiment, a fiber may be wound circumferentially as a secondfiber layer 73 over the woven fiber layer 74. The woven fiber layer 74and circumferential fiber layer 73 may be coated with an outer coatinglayer polymer 16. The angles formed between the woven fibers 71 and 72remain substantially unchanged between the inflated state of the balloon70 and the deflated state of the balloon 70. The balloon 70 is typicallyfolded when deflated, maintaining the angles between the fibers 71 and72 upon deflation.

With reference to FIGS. 19 and 20, non-woven fabrics are shown. Inaccordance with one embodiment, non-woven fabric may be used to form anon-woven fabric layer 75. The non-woven fabric layer 75 may bepositioned directly on the base balloon layer 100. An adhesive layer 126may be used to fix the position of the non-woven fabric layer 75 to thebase balloon layer 100.

The non-woven fabric layer 75 may be formed from parallel taut fibers 76joined with a binding solution such as a polymeric solution. Thenon-woven fabric layer 75 may be cut into a pattern that may allow theapplied fabric layer 75 to cover the base balloon 100 or mandrel 122.

In accordance with another embodiment, the non-woven fabric layer 77 maybe formed as matted fibers 78. The matted fibers 78 may be joined with abinding solution such as a polymeric solution. Typically the anglesbetween the fibers 78 of the matted fiber layer 77 are randomlyassorted. When the binding solution has been applied to the mattedfibers 78, the angles between the fibers 78 does not substantiallychange, regardless of the pressures applied to the surface of the mattedfabric layer 77.

The non-woven fiber layer 75 may be used in place of either the firstfiber layer 12 or the second fiber layer 14. The non-woven fiber layer75 may be applied from pulp, chopped or other forms of individual fiberelements. The matted fiber 77 may be applied by spraying, dipping,co-extrusion onto a carrier, wrapping a pre-formed mat or any othersuitable technique.

In one embodiment, the non-woven fabric layer 75 may be coated with apolymer. In accordance with another embodiment, a fiber 15 may be woundcircumferentially over the non-woven fiber layer 75 to form a secondfiber layer 14. The non-woven fiber layer 75 and circumferential fiberlayer 14 may be coated with a polymer outer coating layer 16.

The fiber-reinforced balloon 10, as described, may be substantiallynon-compliant. That is, the balloon 10 may be characterized by minimalaxial stretch and minimal radial distention and by the ability not toexpand beyond a predetermined size on pressure and to maintainsubstantially a fixed profile.

With reference to FIG. 21, strengthening rods 124 may be placed aroundthe circumference of a balloon 100. Strengthening rods 124 providepressure points on the exterior surface of the inflated balloon,focusing the inflation pressure on the line formed by the outermostsurface of the strengthening rods 124.

In accordance with the disclosed embodiment, the strengthening rods 124are positioned longitudinally around the circumference of the balloon100. The strengthening rods 124 may be made from PEEK(polyetheretherketone) or any other suitable material. The strengtheningrods 124 may be used on a fiber-reinforced balloon, or any otherpolymeric or medical balloon 79.

The strengthening rods 124 may be of any appropriate size, such as thelength 106 of the barrel of the balloon 79. The strengthening rods 124may have any appropriate cross-sectional geometry, including a circularcross-section, a square cross-section, a triangular cross-section, ahexagonal cross-section or any other appropriate shape. In anotherembodiment, the strengthening rods 124 could be fashioned to form anoutward blade surface. The diameter of the strengthening rods 124 mustbe small enough to permit the catheter to be effectively used. Thenumber of strengthening rods and the diameter of the strengthening rods124 will be limited by the cross-sectional diameter of the deflatedmedical balloon including the strengthening rods 124.

With reference to FIG. 22, a cross-section of a balloon 79 withstrengthening rods 124 is shown. The strengthening rods 124 may beplaced in any suitable position relative to the longitudinal axis of theballoon 79. The strengthening rods 124 may be of any suitable length. Inaccordance with the disclosed embodiment, the strengthening rods 124 arepositioned substantially parallel to the long axis of the balloon 79,with a length 106 and position along to the working distance of thebarrel of a balloon 79. A cross-section of the outer tube 210 and theinner tube 212 of the catheter 200 is shown.

The strengthening rods 124 may be secured to the balloon 79 with ahomogeneous outer polymeric layer 16. The homogeneous outer layer 16 mayhave been applied as a film, spray coating, dipping or other suitableprocesses.

When used in angioplasty, the strengthening rods 124 cause the forcegenerated by the pressure of the inflated balloon 79 to be concentratedat the strengthening rod 124 outer surface, thus providing improvedfracturing and movement of the calcifications, lesions or other causesof stenosis inside the affected vessel. When used in stent deployment,the force required to deploy the stent is concentrated at the outersurface of the strengthening rods 124, protecting the balloon surface 79from abrasion or puncture.

With reference to FIG. 23, a fiber-reinforced balloon catheter 200 isshown. A fiber-reinforced medical balloon 10 may typically be fixed nearthe distal end 220 of a catheter tube 208. Balloon catheters 200 havinginflatable balloon attachments have commonly been used for reachinginternal regions of the body for medical treatments, such as in coronaryangioplasty and the like. The fiber-reinforced medical balloon 10 may beexposed to relatively large amounts of pressure during these procedures.The profile of the deflated balloon 10 must be relatively small in orderto be introduced into blood vessels and other small areas of the body.

With reference to FIG. 24, a cross-section of a coaxial catheter tube isshown. A dilating catheter assembly 200 may include a coaxial tubecatheter tube 208, including an outer channel 210 and an inner channel212. The coaxial catheter tube 208 may be adapted to be inserted intothe patient and attached to a connector structure 230 which enables boththe inner 212 and outer channels 210 of the coaxial catheter 200 to besupplied with medium such as radio-contrast fluid.

With reference to FIG. 25, a deflated fiber-reinforced balloon 10 isshown. Catheter 200 assembly has an inner channel 212 and an outerchannel 210 which extend the length of the catheter tube 208. The distalend 220 of the outer tube 210 may be connected to a fiber-reinforcedballoon 10. A folding sheath 222 may be provided for mechanicaldeflation of the fiber-reinforced balloon 10.

With reference to FIG. 26, a coupling device 230, such as a conventionalsyringe luer, may be used to couple the catheter tube 208 to a syringe214 used to inflate the fiber-reinforced balloon 10. The flange portion232 of the coupling device 230 may be adapted to screw into a couplingportion 216 of the syringe 212, forming a seal. The wing portions 234 ofthe coupling device 230 may be used to twist the flange portion 232 intothe coupling portion 216 of the syringe 214. The coupling body 236 ofthe coupling device 230 allows the medium, typically a liquid such as aradio-contrast solution to pass from the syringe 214 to thefiber-reinforced balloon 10.

With reference to FIG. 27, a typical coaxial coupling device 240 withintegral syringes 242 and 244 is shown. In accordance with oneembodiment, the proximal end 207 of the catheter tube 208 including thecoaxial channels 210 and 212 are fed into a connector assembly 218. Theinner channel 212 may be fed into a side arm 224 where it is sealed intoa fitting 225. The fitting 225 may be adapted to receive the front endof syringe 242.

A connecting arrangement 226 may connect the outer channel 210 into themain central arm of connector 240 which may be connected through acoupler assembly 227. The outer channel 210 may be fed into main arm 226where it is sealed into a fitting 228. The fitting 228 may be adapted toreceive the front end of a syringe 244.

With reference to FIG. 28, a blocked vessel 400, such as a blockedcoronary artery, having vessel walls 402 and a vessel channel 406 isshown. The vessel 400 may be blocked by deposits 404 such as plaque. Afiber-reinforced balloon catheter 200 may be used to perform angioplastyas a treatment for a blocked artery 400. A fiber-reinforced balloon 10may be used to open the heart artery 400 as an alternative to open heartsurgery. The fiber-reinforced balloon catheter 200 for use inangioplasty typically includes a small, hollow, flexible tube 208 and afiber reinforced balloon 10 attached near the end of the catheter tube208.

A fiber-reinforced cutting balloon, formed with sharp aterotomesattached to the surface of the fiber reinforced balloon 10, may be usedin some cases, particularly where the deposits 404 are solidified. Afiber-reinforced balloon 79 with strengthening rods 124 may be used insome procedures that may use a cutting balloon. In some cases, thestrengthening rods 124 may be used to score the plaque 404, allowing theinflated fiber-reinforced balloon 10 to open the blockage 404 with lesstrauma than traditional balloon angioplasty.

The fiber-reinforced balloon 10 with strengthening rods 124 may be usedfor first-time interventions and for subsequent interventions. Thefiber-reinforced balloon 10 with strengthening rods 124 may beparticularly useful where the plaque 404 blockages are resistantlesions, particularly found in positions that are difficult or awkwardto address. Bifurcation lesions, for example, occur at theY-intersection of an artery 400. The inflation and deflation of thefiber-reinforced balloon 10 with strengthening rods 124 in this casehelps open the blockage without allowing the plaque 404 to shiftposition. Fiber-reinforced balloons 10 with strengthening rods 124 mayalso be used in the treatment of restenosis. Lesions at the arteryorigins may also be effectively treated using a fiber-reinforced balloon10 with strengthening rods 124.

Angioplasty typically starts with the patient lying on a padded table.Local pain medicine may be given. Catheters may be inserted in anartery, typically near the groin, in the femoral artery. The coronaryarteries 400 may be remotely visualized by using X-rays and dye. Thesevisualizations permit blockages in the heart vessels to be identified.

With reference to FIG. 29, a fiber-reinforced balloon catheter 200 isshown in an inflated state to open a blocked vessel 400. Afiber-reinforced balloon catheter 200 may be inserted into the vesselchannel 406 or near the blockage 404 and inflated, thus widening oropening the blocked vessel 400 and restoring adequate blood flow to theheart muscle.

More specifically, the technique involves use of a fiber-reinforcedcatheter system 200 introduced via the femoral artery under localanesthesia. A pre-shaped guiding catheter may be positioned in theorifice of the coronary artery. Through this guiding catheter a secondfiber-reinforced dilation catheter 200 is advanced into the branches ofthe coronary artery. The fiber-reinforced dilating catheter 200 has anelliptical-shaped distensible fiber-reinforced balloon portion 10 formednear the distal tip 220 of the catheter 200. The balloon portion 10 canbe inflated and deflated. After traversing the stenotic lesion of thecoronary artery 400, the distensible fiber-reinforced balloon portion 10is inflated with fluid under substantial pressure which compresses theatherosclerotic material 404 in a direction generally perpendicular tothe wall 402 of the vessel 400, thereby dilating the lumen of the vessel400.

Balloon valvuloplasty, also known as valvuloplasty, balloon dilation orballoon mitral valvuloplasty, is a non-surgical procedure to openblocked heart valves that may use a fiber-reinforced balloon catheter200.

The procedure involves the insertion of a fiber-reinforced ballooncatheter 200 into the heart. An incision is made between the atria andthe catheter 200 is moved into the blocked valve. When the ballooncatheter 200 is in position, the fiber-reinforced balloon 10 may beinflated and deflated several times to open the valve. Thenon-compliance of the fiber-reinforced balloon 10 under pressure mayprovide benefits in such procedures.

Fiber-reinforced medical balloons 10 may be used in the treatment ofbroken or fractured vertebrae. A fiber-reinforced medical balloon 10 maybe inserted into the region of the fracture. The minimally invasiveprocedure may require only a half-inch incision to insert the medicalballoon 10. The fiber-reinforced balloon 10 may be inflated to anappropriate diameter to raise the collapsed bone. The space created bythe fiber-reinforced balloon 10 may be filled with a cementingsubstance, such as the cement used in hip and knee replacements.

With reference to FIG. 30, a fiber-reinforced medical balloon 10 for acollapsed or ruptured disc is shown. The disk 410 between the vertebrae408 may cease to separate the vertebrae 408 as shown. With reference toFIG. 31, a fiber-reinforced medical balloon 10 may be inserted betweenthe vertebrae 408 and inflated. The space created by thefiber-reinforced balloon 10 may be filled with a cementing substance,such as the cement used in hip and knee replacements.

Kyphoplasty may be used in the treatment of pain associated withosteoporotic compression fractures. The procedure helps stabilize thebone and restores vertebral body height. By inflating a fiber-reinforcedmedical balloon inside the fractured vertebra, the bone position isrestored to allow for the injection of medical cement. This procedurestabilizes the fracture and promotes healing. The stabilization alonecan provide immediate pain relief for many patients.

Kyphoplasty is performed through a small incision in the back. A narrowtube, placed in the incision, is guided to the correct position usingfluoroscopy. The physician uses X-ray images to insert thefiber-reinforced medical balloon into the tube and into the vertebra.The fiber-reinforced balloon is gently inflated, elevating the fractureand returning the pieces of the vertebra to a more normal position. Theinner bone is also compacted, creating a cavity which is filled withmedical bone cement that hardens quickly and stabilizes the bone.Alternatively, the medical balloon may remain in the body and bonecement is filled inside the balloon to stabilize the vertebral body.

Another use of fiber-reinforced medical balloons is in carpal tunneltherapy. Balloon carpal tunnel-plasty may be performed using afiber-reinforced balloon catheter device. The fiber-reinforced ballooncatheter may be used with a specialized nerve protector to stretch andexpand the transverse carpal ligament relieving the symptoms of carpaltunnel syndrome. The procedure may be performed through a one-centimetersize incision at the distal palmar crease ulnar to the palmaris longusin line with the fourth ray. The approach is identical to the singleportal endoscopic technique. The fiber-reinforced medical balloon isused to dilate and expand the transverse carpal ligament to increase thespatial diameter of the carpal tunnel and relieve pressure on the mediannerve alleviating symptoms of carpal tunnel syndrome.

Fiber-reinforced medical balloons may be used in radiation therapy.Where a tumor has been removed, a fiber-reinforced balloon catheter maybe inserted. The inflated fiber-reinforced balloon fills the cavitywhere the tumor was removed from. Radiation is delivered into thefiber-reinforced balloon periodically.

Fiber reinforced medical balloons may be used in the treatment ofnasolacrimal duct obstruction. Nasolacrimal duct obstruction can cause acondition called epiphora, characterized by chronic tearing.Dacryocystoplasty, a non-surgical treatment, is performed as anoutpatient procedure after topical anesthesia. It entails the passage ofa fluoroscopically guided wire through the lacrimal duct, followed bydilation of a fiber-reinforced balloon at the site of obstruction.

Another use of fiber-reinforced medical balloons is the treatment ofbenign prostatic hypertrophy. A fiber-reinforced balloon is inflated todilate the prostatic urethra. Balloon urethroplasty is a therapeuticprocedure intended to manage symptoms associated with benign prostatichypertrophy. Under fluoroscopic guidance, a flexible catheter with afiber-reinforced balloon attachment is placed in the urethra at thelevel of the prostate above the external sphincter. The fiber-reinforcedballoon is then inflated for a short period of time to distend theprostatic urethra. This widening process is intended to relieveobstruction of the urethra caused by the enlarged prostate and toalleviate the symptoms of benign prostatic hypertrophy.

It will be appreciated by those skilled in the art having the benefit ofthis disclosure that this invention provides a non-compliant medicalballoon. It should be understood that the drawings and detaileddescription herein are to be regarded in an illustrative rather than arestrictive manner, and are not intended to limit the invention to theparticular forms and examples disclosed. On the contrary, the inventionincludes any further modifications, changes, rearrangements,substitutions, alternatives, design choices, and embodiments apparent tothose of ordinary skill in the art, without departing from the spiritand scope of this invention, as defined by the following claims. Thus,it is intended that the following claims be interpreted to embrace allsuch further modifications, changes, rearrangements, substitutions,alternatives, design choices, and embodiments.

1. A non-compliant medical balloon, where the balloon may be changedfrom a deflated state to an inflated state by increasing the internalpressure within the balloon, and when the balloon is fully inflated, ithas a length and diameter that do not substantially change as theinternal pressure further increases, the balloon comprising: a balloonlayer having an outer surface, the balloon layer including a base layer,a first reinforcing layer and a second reinforcing layer; the base layerbeing formed of a polymer material; the first reinforcing layer disposedover the base layer, the first reinforcing layer being one of either aplurality of discrete inelastic fibers oriented substantially parallelto the long axis of the balloon and a first layer of textile fabricmaterial, the textile fabric material being one of a woven, knitted,braided and non-woven fabric; the second reinforcing layer being appliedat least partially over the first reinforcing layer, the secondreinforcing layer being one of either at least one inelastic fiberwrapped around the circumference of the balloon substantially transverseto the long axis of the balloon and a second layer of textile fabricmaterial, the textile fabric material being one of a woven, knitted,braided and non-woven fabric; at least one of the first and secondreinforcing layers being one of the first and second layer of textilefabric material; and at least one strengthening rod connected to theouter surface of the balloon layer.
 2. A balloon in accordance withclaim 1, wherein the base layer of the balloon layer comprises a baselayer balloon.
 3. A balloon in accordance with claim 2, wherein the baselayer balloon is formed from a polymeric material that is, by itself,substantially non-compliant.
 4. A balloon in accordance with claim 2,wherein the base layer balloon is formed from a polymeric material thatis, by itself, substantially compliant.
 5. A balloon in accordance withclaim 1, wherein the base layer of the balloon layer is formed of apolymer that is applied in liquid form on a mandrel in the shape of aninflated balloon and cured into a solid form, the material of the curedsolid form being, by itself, substantially non-compliant.
 6. A balloonin accordance with claim 1, wherein the base layer of the balloon layeris formed of a polymer that is applied in liquid form on a mandrel inthe shape of an inflated balloon and cured into a solid form, thematerial of the cured solid form being, by itself, substantiallycompliant.
 7. A balloon in accordance with claim 1, wherein a pluralityof strengthening rods are disposed substantially symmetrically aroundthe periphery of the outer surface of the balloon.
 8. A balloon inaccordance with claim 1, wherein the strengthening rods are disposedasymmetrically on the outer surface of the balloon.
 9. A balloon inaccordance with claim 8, wherein the strengthening rods form an outwardblade surface concentrating the force generated by the pressure of theinflated balloon in a particular direction.
 10. A balloon in accordancewith claim 1, wherein when the balloon is fully inflated, the balloonlayer includes a first cone region formed at one end having a first coneangle and a second cone region formed at a second end having a secondcone angle.
 11. A balloon in accordance with claim 10, wherein when theballoon is fully inflated, the first cone angle and the second coneangle are substantially identical to one another.
 12. A balloon inaccordance with claim 10, wherein when the balloon is fully inflated,the first cone angle and the second cone angle are substantiallydifferent from one another.
 13. A non-compliant medical ballooncatheter, where the balloon may be changed from a deflated state to aninflated state by increasing the internal pressure within the balloon,and when the balloon is fully inflated, it has a length and diameterthat do not substantially change as the internal pressure furtherincreases, the balloon catheter comprising: a catheter tube; a balloonlayer having an outer surface, the balloon layer including a base layer,a first reinforcing layer, and a second reinforcing layer; the baselayer being formed of a polymer material; the first reinforcing layeroverlying the base layer; the second reinforcing layer at leastpartially overlying the first reinforcing layer; one of the first andsecond reinforcing layers being a textile fabric material, the textilefabric material being one of a woven, knitted, braided and non-wovenfabric comprising a plurality of fibers oriented at angles to oneanother; the other of the first and second reinforcing layers beingformed of inelastic fibers aligned in one of either a first directionand a second direction, the first direction being substantially parallelto the long axis of the balloon and the second direction being aroundthe circumference of the balloon substantially transverse to the longaxis of the balloon; and at least one strengthening rod connected to theouter surface of the balloon layer.
 14. A balloon catheter in accordancewith claim 13, wherein the base layer of the balloon layer is formedfrom a polymeric material that is, by itself, substantiallynon-compliant.
 15. A balloon catheter in accordance with claim 13,wherein the base layer of the balloon layer is formed from a polymericmaterial that is, by itself, substantially compliant.
 16. A method offorming a non-compliant medical balloon that may be changed from adeflated state to an inflated state by increasing the internal pressurewithin the balloon, the method comprising the following steps: forming abase layer from a polymer material in the shape of the inflated balloonhaving a long axis and a circumference; applying a first reinforcinglayer over the base layer, the first reinforcing layer being one ofeither a plurality of discrete inelastic fibers oriented substantiallyparallel to the long axis of the balloon and a first layer of textilefabric material, the textile fabric material being one of a woven,knitted, braided and non-woven fabric; applying a second reinforcinglayer at least partially over the first reinforcing layer, the secondreinforcing layer being one of either at least one inelastic fiberwrapped around the circumference of the balloon substantially transverseto the long axis of the balloon and a second layer of textile fabricmaterial, the textile fabric material being one of a woven, knitted,braided and non-woven fabric; where at least one of the first and secondreinforcing layers is one of the first and second layer of textilefabric material; and affixing at least one strengthening rod to theouter surface of the balloon layer formed by the previous steps.
 17. Amethod in accordance with claim 16, wherein the base layer is formed ofa substantially non-compliant material that is internally pressurized tomaintain its shape during the application of the first and secondreinforcing layers.
 18. A method in accordance with claim 16, whereinthe step of forming a base layer further comprises: applying a polymerin liquid form over a mandrel having the shape desired for the inflatedballoon; and curing the polymer into a solid form having the shape ofthe mandrel.
 19. A method in accordance with claim 18, wherein the curedpolymer in solid form is, by itself, substantially non-compliant.
 20. Amethod in accordance with claim 18, wherein the cured polymer in solidform is, by itself, substantially compliant.